Registration Dossier
Registration Dossier
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EC number: 204-439-0 | CAS number: 120-95-6
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 2,4-di-tert-pentylphenol
- EC Number:
- 204-439-0
- EC Name:
- 2,4-di-tert-pentylphenol
- Cas Number:
- 120-95-6
- Molecular formula:
- C16H26O
- IUPAC Name:
- 2,4-bis(2-methylbutan-2-yl)phenol
- Details on test material:
- - Name of test material (as cited in study report): 2,4-di-tert-Amylphenol
- Physical state: liquid
- Analytical purity: 99.61%
- Purity test date: 1998-01-28
- Lot/batch No.: not mentioned
- Date of production: 1998-01-14
- Stability under test conditions: > 1 year
- Storage condition of test material: in tightly closed containers, under exhaust hood
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Winkelmann, Borchen, Germany
- Age at study initiation: healthy adult animal
- Weight at study initiation: 2.6 kg
- Housing: conventional, single housing in stainless steel cages
- Diet (e.g. ad libitum): Ssniff K4 complete feed for rabbits, ad libitum, supplied by Ssniff Spezialfutter GmbH, Soest, Germany
- Water (e.g. ad libitum): Drinking water ad libitum, supplied by Gelsenwasser, Wasserwerk Haltern, Germany
- Acclimation period: 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 30-70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 cm³ - Duration of treatment / exposure:
- Because of supposed corrosive skin irritations caused by the test substance, first the animal was treated with an exposure time of three minutes (open patch) on the right flank. One hour after patch removal no severe skin lesions were observed. Therefore the other flank of the animal was treated with an exposure time of 1 hour.
- Observation period:
- up to 23 days
- Number of animals:
- 1
- Details on study design:
- TEST SITE
- Area of exposure: 6 cm² of shaved skin of the dorsal area of the trunk of the animal
- % coverage: not mentioned
- Type of wrap if used: on the application area a gauze patch was placed, the patch was held in place with a non-irritant plaster
REMOVAL OF TEST SUBSTANCE
- Washing (if done): with warm water
- Time after start of exposure: 1 hour
SCORING SYSTEM: according to OECD guideline 404
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- other: 3 minutes application
- Time point:
- other: 24, 48 and 72 hour
- Score:
- 3.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 17 days
- Irritation parameter:
- edema score
- Basis:
- other: 3 minutes application
- Time point:
- other: 24, 48 and 72 hour
- Score:
- 3.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 17 days
- Irritation parameter:
- erythema score
- Basis:
- other: 1 hour application
- Time point:
- other: 24. 48 and 72 hour
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- fully reversible within: 17 days
- Irritation parameter:
- edema score
- Basis:
- other: 1 hour application
- Time point:
- other: 24, 48 and 72 hour
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- fully reversible within: 17 days
Any other information on results incl. tables
Table: Irritant/corrosive response data for each animal at each observation time of each animal from the test
Score at time point / Reversibility |
Erythema |
Edema |
Score: 3 min / 1 hour appl. |
Score: 3 min / 1 hour appl. |
|
60 min |
2 / 2 |
2 / 2 |
24 h |
3 / 4 |
3 / 4 |
48 h |
3 / 4 |
3 / 4 |
72 h |
4 / 4 |
4 / 4 |
Average 24h, 48h, 72h |
3.33 / 4.0 |
3.33 / 4.0 |
Reversibility*) |
c. / c. |
c. / c. |
Average time (unit) for reversion |
17 d / 17 d |
17 d / 17 d |
*) Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible
Applicant's summary and conclusion
- Interpretation of results:
- corrosive
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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